NCT06002841 appears in searches about adipose research and cell therapy, and it is rarely what the searcher expects. The record describes a small Brazilian study of mesenchymal-cell-derived extracellular vesicles in acute respiratory failure, and its status has read Unknown since 2023. This post walks that record field by field.
TLDR: NCT06002841 is a Phase 1/Phase 2 study of mesenchymal-cell-derived extracellular vesicles for acute respiratory failure associated with SARS-CoV-2 and other causes, sponsored by the D’Or Institute for Research and Education at one site in Salvador, Bahia, Brazil. Estimated enrollment is 15, with 10 assigned to vesicles and 5 to placebo. The status is Unknown, last verified August 2023. It is not an adipose trial, not a cell injection study, and not evidence of benefit. Banking adipose tissue creates no treatment pathway and cannot guarantee a place in any study.
Important Disclaimer: Save My Fat is a tissue preservation connector and does not provide FDA-approved treatments or cures. Describing a registered trial is not an endorsement of it, and Save My Fat does not guarantee eligibility, access, or clinical benefit from any study or product named here. Extracellular vesicles and exosomes appear in this article for educational purposes only, remain investigational, and are not a Save My Fat service. Readers should consult their own licensed healthcare professionals before acting on any of it.
A clinic page or a social ad drops an NCT number, and the number does its work. Registration on a government registry looks like legitimacy, and few readers open the record to check.
Search for a registered adipose derived stem cell trial in 2026 and NCT06002841 can surface. Open it, and none of those words hold up. It is not adipose, because the record never names the tissue. It is not a stem cell injection, because the intervention is extracellular vesicles. And nobody can join it, because the record has not been verified since August 2023.
What NCT06002841 Actually Studies
The registered title is “Extracellular Vesicles From Mesenchymal Cells in the Treatment of Acute Respiratory Failure Associated With SARS-CoV-2 and Other Etiologies: a Clinical Trial, Randomized, Double-blind.” Nearly every detail that matters sits there. The study record names the D’Or Institute for Research and Education in Brazil as sponsor, with Hospital Sao Rafael, FAPERJ, and the Oswaldo Cruz Foundation as collaborators. Listed conditions are SARS, ARDS, and pneumonia.
The intervention is not a cell injection. It is mesenchymal-cell-derived extracellular vesicles, two intravenous infusions of 25 mL of Plasma-Lyte A, 48 hours apart, against a placebo of equal volume. Vesicles are particles released by cells. They are not cells.
The record also never states which tissue those mesenchymal cells came from. When this number gets called an adipose study, that word is added by whoever repeats it.
The NCT06002841 Clinical Trial Explained, Field by Field
Registry records are structured, and every field answers a different question. Reading them in order keeps assumptions out of the gaps. The table pairs each entry with what it actually supports.
| Registry field | What the record says | What it supports |
|---|---|---|
| Sponsor | D’Or Institute for Research and Education, Brazil | Who owns the record |
| Collaborators | Hospital Sao Rafael, FAPERJ, Oswaldo Cruz Foundation | Partners, not endorsement |
| Phase | Phase 1/Phase 2 | Early safety, first look at activity |
| Overall status | Unknown | A stale, unverified record |
| Last known status | Not yet recruiting | Nobody had enrolled |
| Last verified | August 2023 | Almost three years ago |
| Last update posted | August 21, 2023 | Nothing posted since |
| Conditions | SARS, ARDS, pneumonia | Acute respiratory failure |
| Intervention | Extracellular vesicles, two IV infusions of 25 mL Plasma-Lyte A, 48 hours apart | Vesicles, not cells |
| Comparator | Placebo of equal volume | Randomized, double-blind |
| Enrollment | 15 estimated, 10 vesicles and 5 placebo | Planned, not achieved, and small |
| Locations | Single site, Salvador, Bahia, Brazil | One site, one population |
Together those fields describe a careful but very small early study that stopped being maintained in 2023. Nothing in it supports a claim about the product.
What an Unknown Status Means on ClinicalTrials.gov
Status is the field readers misjudge most. The ClinicalTrials.gov glossary defines Unknown, verbatim, as “A study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years.” It does not say the study stopped, and it does not say it is running.
Unknown describes the record, not the science. Federal reporting rules require a status change within 30 calendar days and prior information to stay public, and the registry about page states that “Information about each study is permanently available in the database, even after the study ends.”
So the honest reading is narrow. As of August 2023 the sponsor had not begun recruiting, and nobody has confirmed anything since. Compare the Mayo adipose MSC study in multiple system atrophy, listed as Active, not recruiting, with 71 actual participants and a June 2026 verification. Anyone tracking active adipose trials can see the difference.
Phase 1/Phase 2 Is a Safety Question, Not an Answer
A combined Phase 1/Phase 2 label means the study does two early jobs at once. It checks safety and tolerability, then takes a first look at whether anything measurable happens. Our breakdown of clinical trial phases explains how the later, larger phases carry the efficacy questions.
Early-phase designs are usually not sized to demonstrate a difference between groups. Early research is preliminary and more studies are needed. When marketing cites a Phase 1/Phase 2 registration as though it were a result, the label does work the study was never built to do.
What 15 Participants at One Site Can and Cannot Show
Enrollment here reads 15 estimated, not 15 actual. Estimated means planned. Actual means counted. Because the last known status was Not yet recruiting, no public confirmation exists that any of those 15 people enrolled.
Even at full enrollment, a split of 10 to vesicles and 5 to placebo could only detect a very large difference. Small early studies are how careful research begins, and also how thin claims get dressed up.
One site in Salvador, Bahia means one setting and one population. Single-center findings start larger work rather than settling anything. Add the August 2023 timestamp, and what remains is a plan, not a finding.
Extracellular Vesicles Are Not Cells, and None Are FDA Approved
Extracellular vesicles, often marketed as exosomes, are membrane particles released by cells. Because a vesicle product contains no living cells, its biology, manufacturing, and regulatory questions all differ from a cell product. Researchers report such studies against MISEV2023, the current minimal information framework for the field.
The regulatory position is not ambiguous. The FDA consumer alert on regenerative medicine products states that no exosome product is FDA approved, and that blood-forming stem cells from cord blood are the only approved stem cell products. It names COVID-19 among conditions these products are not approved to address. Save My Fat raises vesicles for education only, never as a service, and individual results may vary and outcomes cannot be predicted.
How to Read Any Trial Record the Same Way
Ask the same questions every time, in order. What is the intervention, in the record’s own words? What source is named? What is the status, and when was it last verified? Is enrollment estimated or actual? How many sites, in which country? Are results posted?
Then ask who is showing you the record and why. A clinic citing an NCT number is not automatically part of that study, and registration is a listing, not a review. Our guide to finding legitimate trials covers the sourcing steps.
Frequently Asked Questions
What condition and intervention does NCT06002841 investigate?
The record lists SARS, ARDS, and pneumonia, grouped as acute respiratory failure associated with SARS-CoV-2 and other causes. The intervention is mesenchymal-cell-derived extracellular vesicles, two intravenous infusions of 25 mL of Plasma-Lyte A, 48 hours apart, against placebo. It is not a cell injection, and no tissue source is named.
What phase is this trial currently in?
It is registered as Phase 1/Phase 2, a combined early design examining safety and tolerability first and activity second. Early-phase studies are not built to demonstrate benefit. Because the status is Unknown and the last known status was Not yet recruiting, nothing confirms it moved past planning.
Who is eligible to enroll?
This article cannot publish eligibility criteria, because the verified source material supplies none. The verified detail matters more anyway: the last known status was Not yet recruiting, so no site was enrolling as of August 2023. Review the entry with a physician before considering research participation.
Where is this trial being conducted?
The record lists a single site in Salvador, Bahia, Brazil. The sponsor is the D’Or Institute for Research and Education, with Hospital Sao Rafael, FAPERJ, and the Oswaldo Cruz Foundation as collaborators. A single-site design limits how far any result could generalize.
Does registration on ClinicalTrials.gov mean this treatment works?
No. Registration is a public listing sponsors are required to make, not a scientific verdict and not an approval. Federal rules call for registration within 21 days of enrolling the first participant and results generally within one year after primary completion. Neither step evaluates benefit.
What does an Unknown status tell me about the study today?
It tells you the record stopped being maintained. Unknown applies when a study’s last known status was recruiting, not yet recruiting, or active and not recruiting, and the record passed its completion date without verification in two years. It says nothing about safety. Treat it as unconfirmed.
Key Takeaways
NCT06002841 is a useful record precisely because it defeats the assumption most people bring to it. It is a Phase 1/Phase 2 study of mesenchymal-cell-derived extracellular vesicles for acute respiratory failure, planned for 15 participants at one site in Brazil. The tissue source is never named, so nobody can call it an adipose study. The intervention is vesicles rather than cells, so it is not a cell injection study.
The status is Unknown and the record was last verified in August 2023, so it is neither recruiting nor confirmed as ongoing. No exosome or extracellular vesicle product has FDA approval, and Save My Fat does not offer them. The method carries over. Read the intervention, the source, the phase, the status, the verification date, and the site count before you read anyone’s summary. The fields are the evidence. The summary is an opinion.
Save My Fat operates as a tissue preservation service, not a medical practice or treatment provider. Stem cell and regenerative medicine regulations vary by state, including specific informed-consent and disclosure requirements in Florida, Utah, and Nevada governing tissue and stem cell services. Banking adipose tissue does not connect patients to any treatment pathway, and any future use depends on FDA regulatory status, physician guidance, and the availability of approved or investigational pathways at that time.
Readers weighing adipose tissue banking for potential future use can review current options and pricing, or contact our team with questions about the process.
Save My Fat partners with L2 Bio for laboratory processing and storage.
This article is for educational purposes only and does not constitute medical or legal advice. Legal and medical review including neurology and neurosurgery input is required before publication. Please consult your neurologist or neurosurgeon before making any decisions about banking, treatment, or research participation.
About the author: Oscar Tellez is the founder and CEO of Save My Fat. He holds a Bachelor of Science in Exercise Science and Health Promotion from Florida Atlantic University. He has spent more than a decade in the regenerative medicine industry across product distribution, laboratory and vendor relationships, and provider training. He is not a licensed clinician, and this article is educational, not medical advice.
Related guide: adipose stem cell trials.
